Table of Contents When developing new vaccines, patient safety is paramount. Phase I vaccine trials determine safety and efficacy before public release. Data collection is crucial for evaluating the vaccine’s performance. Electronic Patient Reported Outcomes (ePRO) are valuable tools in ensuring patient safety during Phase I vaccine trials. This article explores the importance of… Continue reading Phase I Vaccine Trials & ePRO: Ensuring Patient Safety
Artificial intelligence (AI) and machine learning (ML) herald a new era of regulatory operations in clinical trials. These advanced technologies are revolutionizing how companies manage regulatory data, predict outcomes, and ensure compliance, ultimately leading to greater efficiency and accuracy. From the IQVIA article published on its website on June 10, 2024, we would like… Continue reading 4 Key Benefits of AI & Machine Learning in Clinical Trials
From the ideation of the scientific question, sponsors can consider integrating ePRO tools in protocol designs. Decentralized and hybrid clinical trials can widen the data points and make the most of each trial. Here we share five steps to introduce an ePRO into a protocol: Define the objectives an ePRO tool can address: Identify the… Continue reading How to include an ePRO in your protocol design
Table of Contents Effective clinical trial management is critical to success in drug development. A clinical trial management system (CTMS) is an essential tool that enables sponsors and clinical research organizations (CROs) to facilitate their trial processes. A CTMS centralizes and automates many trial management functions, from planning to study closure. CTMSs help teams improve… Continue reading What is a CTMS? The Clinical Trial Management Key
Table of Contents What is electronic patient-reported outcomes (ePRO)? ePRO stands for “Electronic Patient-Reported Outcomes.” It is a tool that allows patients to record electronically and submit their health outcomes digitally using devices such as smartphones, tablets, or computers. Electronic patient-reported outcomes (ePRO) is an innovative tool that transforms how data is collected and analyzed… Continue reading What is ePRO, Electronic Patient-Reported Outcome?
Table of Contents The global eCOA market is poised for significant growth in the coming years. Grand View Research shows the market is expected to reach $20.5 billion by 2028. eCOA (electronic Clinical Outcome Assessment) uses electronic tools and technologies to collect and evaluate patient outcome data in clinical trials and clinical research. It allows… Continue reading Electronic Clinical Outcome Assessment (eCOA): What is and Who Uses it?
Poor patient reporting adherence can prolong the trial duration by increasing the time required to gather complete and accurate data. This can extend the overall cost of the trial while burdening the study team and site, and compromise future submissions. Patient reporting adherence facilitates the early identification of symptoms and risk factors, prevents dropouts,… Continue reading Leveraging Technology to Elevate Patient Reporting Adherence in Vaccine Clinical Trials: Reaching +98% Adherence Rates
Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are two types of electronic data collection methods. While they may seem similar, there are some differences between them that are important to acknowledge. ePRO involves patients reporting their own health outcomes directly to their healthcare provider or research team. This is usually… Continue reading Differences and similarities between an eCOA and ePRO
An FDA 2020 report (1) has shown a 28% decrease in underrepresented populations in United States clinical trials compared to 2018. Moreover, the 2022 FDA guidance for the industry to improve underrepresented racial and ethnic participants’ enrollment is a call to action to get clinical data that really reflects the diversity of the population expected… Continue reading Rising Equity in Clinical Trials and Emerging Countries Through Tech
ePRO/eCOA Capabilities to better conduct Clinical Studies ePRO/eCOA tools have revolutionized the clinical research industry. The first concept was raised a decade ago, but the idea of integrations between systems or interoperability was far from easy. In the past three years, the industry has experienced a boom of new technology development, broadening the data source… Continue reading Seven ePRO/eCOA Capabilities to Better Conduct Clinical Studies in Latin America
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